Wound vacuum therapy dressing kit

ABSTRACT

A wound vacuum therapy dressing kit is provided for use with a wound drainage system having a vacuum source. The kit may include a wound dressing member, a sealing film, and a wound measurement device. The wound dressing member may include a wound contacting surface configured to be in contact with and generally conform to a wound surface of a patient. The member may be adapted to be coupled to the vacuum source for communicating suction from the vacuum source to the wound surface. The sealing film of the kit may be provided for placement over the member and may be configured to adhere to a patient&#39;s healthy skin surrounding the wound. The wound measurement device may include a transparent top portion and a transparent bottom portion configured for placement adjacent the wound surface. The top portion may include a drawing surface and a grid associated with the drawing surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national counterpart application ofinternational application Ser. No. PCT/US02/41231 filed Dec. 20, 2002,which claims the benefit of U.S. provisional application Ser. No.60/344,620 filed Dec. 26, 2001.

BACKGROUND OF THE INVENTION

The present invention relates to wound dressing kits, and particularlyto the provision of kits for use with wound vacuum systems.

The prior art contemplates kits for wound medical treatment, such asfirst aid kits, for example. Such kits usually include bandages fortreating wounds, gauze, scissors, and/or medical tape. Conventionalkits, however, are not equipped with specialized devices for treatingchronic open wounds, such as decubitus ulcers.

SUMMARY OF THE INVENTION

The present invention comprises one or more of the following featuresdiscussed below, or combinations thereof:

A wound vacuum therapy dressing kit is provided for use with a wounddrainage system. The contents of the kit are provided to aid a caregiverwhen installing or changing the vacuum bandage. The kit may include awound dressing member having a wound contacting surface that may beconfigured to be in contact with and generally conform to the woundsurface. The member may further include a plurality of discrete holesformed in the wound contacting surface and a port configured forcommunication with the vacuum source. The member may further include apassageway between each hole and the port. The kit may further includevarious components or accessory items that are used in conjunction withthe wound dressing member.

An illustrative kit may include a sealing film for placement over themember. The sealing film may adhere to a patient's healthy skinsurrounding the wound. The illustrative kit may also include a woundmeasurement device for measuring and recording the size of the wound atthe time the caregiver changes the vacuum bandage. The wound measurementdevice may include a transparent top portion and a transparent bottomportion removably coupled to the top portion. The bottom portion may beplaced adjacent the wound surface and the top portion may be folded forplacement adjacent the bottom portion. The top portion may include adrawing surface and a grid coupled to the drawing surface on which thecaregiver may draw or trace the size of the wound for keeping with thepatient's records, for example.

A kit in accordance with this disclosure may further include a tubeguide that may be coupled to the healthy skin surrounding the patient'swound. The tube guide may have an aperture for receiving and positioninga vacuum tube coupled to the member and to a vacuum source. The tubeguide may include a curved upper surface for contact with the sealingfilm. When the bandage is assembled, the film may be draped over theupper surface of the tube guide to couple with the upper surface of thetube guide and effect a seal around the tube guide. The tube guide mayfurther include a flat bottom surface and an adhesive layer coupled tothe bottom surface. The adhesive layer may couple the bottom surface ofthe guide to the patient's healthy skin surrounding the wound.

The guide may further include an opening through a side wall into theaperture, which opening may be defined by confronting first and secondsurfaces. The opening of the guide may be in communication with theaperture. The first surface and the second surface may be generallyparallel to each other and may be inclined with respect to the bottomsurface. The tube may be placed within the aperture by moving the firstsurface and second surface away from each other and passing the tubethrough the opening for placement within the aperture. The sealing filmdraped over the guide may effectively cause the first surface to abutthe second surface thus sealing the opening.

The kit may further include a patch sheet. The patch sheet may include afirst layer and a second layer releasably coupled to the first layer.The second layer may include an adhesive and may be die cut to formcircular patches and rectangular strips. The patches and strips may beused with the sealing film to repair and seal any leaks, tears, orholes, for example, to provide a sealed environment about the wound andcreate a vacuum space above the wound.

It will be appreciated that the kit may also include a variety ofcomponents such as those shown and described in the disclosures of thepatent applications, patent publications, and issued patentsincorporated by reference herein including vents, venting lines, valves,stopcocks, multi-lumen tubes and tubing sets, wound inserts, woundpacking, and external catheter access collars, for example.

Features of the disclosure will become apparent to those skilled in theart upon consideration of the following detailed description of thepreferred embodiments exemplifying the best mode of carrying out thedisclosure as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a part perspective, part diagrammatic view of a wound carebandage showing the wound care bandage located on the leg of a patientand coupled to both a vacuum source and an irrigation source through theuse of a switch valve;

FIG. 2 is an exploded perspective view of the wound care bandagepositioned above a wound bed showing a wound contacting layer and acover of the bandage which cooperate to form a wound dressing member forplacement within the wound bed, and also showing a sealing film to coverthe member and seal about the wound;

FIG. 3 is a bottom perspective view of a portion of the member providedin a wound vacuum therapy dressing kit in accordance with thisdisclosure showing a smooth wound contacting surface of the member andalso showing the transparent nature of the member;

FIG. 4 is a perspective view showing components of one example of a kitincluding a pair of pre-packaged gloves, scissors, two cotton-tippedapplicators, a wound measurement device, pre-packaged gauze,hypo-allergenic tape, a skin protectant, a sealing film, and the thin,flexible wound dressing member of FIGS. 1-3;

FIG. 5 is a top plan view of the wound measurement device;

FIG. 6 is a sectional view of the wound measurement device of the kitshowing the wound measurement device adjacent a wound for measuring thesize of the wound by tracing an outline of the wound onto the device;

FIG. 7 is a top plan view of a patch sheet of the kit showing anadhesive layer of the sheet that is die-cut into rectangular strips andcircular patches to be used to repair any leaks that occur during thecourse of treatment;

FIG. 8 is a side elevation view of the patch sheet of FIG. 7;

FIG. 9 is a side elevation view of the sealing film of the kit showingthe sealing film including an adhesive backing for covering the woundand showing the film including release liners which are progressivelyremovable to expose the adhesive;

FIG. 10 is a perspective view of a tube guide which is included in somekits and which is configured for adhering to the healthy skin of thepatient surrounding the wound and showing the tube guide having anopening that receives a tube which extends between the wound dressingmember and the vacuum and/or irrigation source;

FIG. 11 is a front elevation view of the tube guide shown in FIG. 10;and

FIG. 12 is a perspective view of the bandage within the wound bed of apatient and showing the tube guide of FIGS. 10 and 11 coupled to thepatient's healthy skin adjacent the wound and receiving the tubetherethrough.

DETAILED DESCRIPTION OF THE DRAWINGS

A wound vacuum therapy dressing kit 10 is provided for applying orchanging a vacuum dressing or bandage 11 that is used for treatment of achronic open wound 12 having a wound surface 14, such as that shown inFIGS. 2 and 6, for example. Generally, bandage 11 includes a wounddressing member 19 that is placed on the wound surface 14 and a sealingfilm 22 to cover the member 19 and seal about the wound 12 to create avacuum space above the wound 12. Member 19 is configured forcommunication with a vacuum source 16 and optionally an irrigationsource 18, as shown in FIG. 1. The bandage 11 and vacuum source 16 makeup a wound drainage system. It is also within this disclosure to includea wound drainage system having irrigation source 18, although irrigationsource 18 is not required.

Bandage 11 promotes the healing of wound 12 by providing vacuum therapyto wound 12 to promote blood flow and remove exudate from wound surface14 and by providing for irrigation of the wound with fluids such assaline, for example. An illustrative wound treatment apparatus having awound temperature control system, a medicine delivery system, and adrainage system is disclosed in U.S. Pat. No. 6,458,109. An illustrativevacuum and irrigation system is disclosed in U.S. Patent Publication No.US 2002/0161317 A1. Additionally, an illustrative vacuum bandage isdisclosed in U.S. Pat. No. 6,685,681. Alternative vacuum bandages aredisclosed in U.S. Patent Publication No. US 2002/0082567 A1. Further, avacuum bandage system including a controller of the system is disclosedin U.S. Patent Application Publication No. US 2002-0198504A1, titledWOUND TREATMENT APPARATUS and in U.S. Patent Application Publication No.US 2002-0198503 A1,titled WOUND TREATMENT APPARATUS. All of thesepublications and patents are hereby incorporated herein by reference.

Optionally, a packing material such as gauze 20 shown in FIG. 4, forexample, is provided for placement over the member 19 and under film 22.It will be appreciated, however, that some caregivers may choose toleave the gauze 20 out of the bandage 11 and place the sealing film 22directly over and in direct contact with member 19 to seal to thepatient's healthy skin 62 surrounding the wound 12. Further, it will beappreciated that gauze 20 may be used to serve functions other thanpacking. For example, gauze 20 may be used to absorb excess liquid fromthe wound surface 14 prior to placing member 19 onto wound surface 14.It will be appreciated that a variety of other materials may be used aspacking.

Vacuum bandages 11 are changed from time to time by caregivers. Forexample, as a patient's wound heals and becomes smaller, one bandage 11is removed and a new, smaller bandage 11 is applied. Wound vacuumtherapy dressing changes often require many medical supplies that acaregiver has conventionally sourced separately. Kit 10 contains all, orsubstantially all, of the necessary supplies or accessory items forapplying or changing a vacuum wound therapy bandage in one package, thusrelieving the caregiver of the time and expense associated withordering, stocking, and locating each of these items separately. Thus,kit 10 increases productivity of the caregiver.

In one embodiment, kit 10 includes member 19, gauze 20 such as KERLIX™non-linting gauze by Kendall, sealing film 22 such as 3M's TEGADERM®brand sealing film, scissors 24, a pair of pre-packaged gloves 26,hypo-allergenic tape 28 such as DERMIVIEW® brand tape made by Johnson &Johnson, two sterile cotton swabs 30, a wound measurement device 32, anda skin protectant 34, as shown in FIG. 4. Although each component of kit10 is disclosed above with respect to a certain brand, it is within thescope of this disclosure to include any brand or type of theabove-mentioned products. For example, OPSITE FLEXIGRID® semipermeabledressing made by Smith & Nephew may be used in lieu of TEGADERM® sealingfilm in some embodiments.

Member 19, as shown in more detail in FIGS. 2 and 3, is made ofnon-porous, non-adhesive, and generally non-compressible silicone.Vacuum source 16 acts to remove exudate by creating a negative pressureabove the wound surface 14 which draws the exudate up through member 19.Irrigation source 18 acts to irrigate the wound surface 14 by supplyinga fluid for flushing through member 19 onto wound surface 14. Member 19is substantially transparent and has a rectangular shape, as shown inFIGS. 2-4. However, it is within the scope of this disclosure to includein kit 10 one or more members having other suitable shapes. Thus, thewound dressing members of the kit 10 may have a variety of sizes,configurations and durometers or degrees of softness and may beconfigured to conform to different portions of a patient's body such asthe heel, sternum, elbow, etc. Examples of some alternative wounddressing members are shown in U.S. Pat. No. 6,685,681, and U.S. PatentApplication Nos. US 2002/082567 A1, and US 2002/0161346 A1,thedisclosures of which are hereby incorporated by reference herein. Yetanother illustrative wound dressing members is disclosed in PCTInternational Publication No. WO 03/086232; which was filed concurrentlyherewith; which is titled ACCESS OPENINGS IN VACUUM BANDAGE which ishereby incorporated by reference herein.

Illustrative member 19, shown in FIGS. 2-4, includes a wound contactinglayer 36 and a cover 38 coupled to layer 36. Member 19 also includes aconnector 40 coupled to cover 38 for communication with vacuum source 16and/or irrigation source 18 via a tube 41. Layer 36, cover 38, andconnector 40 are each made of a medical grade silicone or other type ofpliable elastomer. Two companies, for example, which manufacture suchmedical grade silicone are GE Silicones and NuSil Technology. It iswithin the scope of this disclosure, however, to include a member madeof any type of thin, flexible material which is illustrativelynon-porous and non-foam-like. This thin, flexible material is alsoillustratively generally non-absorptive. For example, materials such aspolyvinylchloride (PVC), PVC free of diethylhexyl phthalate (DEHP-freePVC), polyurethane, or polyethylene may be used in the manufacture ofmember 19. Further, layer 36, cover 38, and connector 40 may each bemolded to include anti-microbial constituents. For example, it is withinthe scope of this disclosure to impregnate member 19 with silver ionswhich are known anti-microbials.

Member 19, including layer 36, cover 38, and connector 40, is also madeof a generally non-adhesive material. Therefore, layer 38, which liesadjacent to wound surface 14, does not adhere to wound surface 14.Further, member 19 is solid in nature and generally non-compressible.For example, when a negative pressure is applied to member, 19, athickness, 21, of member 19, as shown in FIG. 3, remains relativelyconstant. Further, as shown in FIG. 3, member 19 is substantiallytransparent. Therefore, a caregiver or user is able to see the wound 12through member 19 when member 19 is placed adjacent to wound surface 14.This transparency allows the caregiver to view the progress of thehealing of wound 12.

Layer 36 includes a wound contacting surface 42 and an upper or oppositesurface 44. Wound contacting surface 42, or portions thereof, contactsand generally conforms to the wound surface 14. Opposite surface 44includes a central area 46 and a plurality of channels 48 extendingradially away from central area 46. Concentric channels 49 are alsoformed in layer 36, as shown in FIGS. 2 and 3. Central area 46 isrecessed relative to the portions of upper surface 44 between channels48, 49 as shown in FIG. 2. Channels 48 are open at the sides and ends ofmember 19. Illustratively, each channel 48, 49 is 0.030 inch (0.762 mm)wide and 0.030 inch (0.762 mm) deep. It is within the scope of thisdisclosure, however, to include channels 48, 49 of opposite surface 44having various widths and depths suitable for the present application.As shown in FIG. 2, central area 46 of layer 36 is provided tocommunicate with the vacuum source 16 and irrigation source 18 throughcover 38, as will be described below.

A plurality of radially extending protrusions or bosses 50 arepositioned around central area 46. Bosses 50 are positioned betweencentral area 46 and channels 48, 49, as shown in FIG. 2. Bosses 50prevent central area 46 from collapsing in on a port 52 of cover 38 andforming an unwanted seal which would effectively block air flow throughport 52 while suction is applied to bandage 11. Port 52 communicateswith the vacuum source 16 and/or the irrigation source 18 via connecter40 and tube 41, as shown in FIGS. 1 and 2. As mentioned above, port 52is in communication with central area 46 of layer 36. Illustratively,four bosses 50 are shown in FIG. 2. However, it is within the scope ofthis disclosure to provide any number of bosses 50 or the like incentral area 46 of layer 36 to prevent central area 46 from sealing offport 52 of cover 38 suction is applied to bandage 11. Further, it iswithin the scope of this disclosure to include bosses 50 having atapered cross-section, for example, or to include a boss or bosseshaving any shape that prevents central area 46 from sealing off port 52when suction is applied to bandage 11. Alternative or supplementalbosses 51 are shown in FIG. 3. Bosses 51 are positioned between bosses50 and further prevent central area 46 collapsing on port 52 and formingan unwanted seal blocking air flow through port 52 while suction isapplied to bandage 11. Alternative bosses are generally rectangularlyshaped and extend inwardly from channels 48 toward port 52.

Connecter 40, as shown in FIG. 2, is a tubal port coupled to a topsurface 54 of cover 38 and in communication with port 52 of cover 38. Asmentioned before, it is within the scope of this disclosure forconnecter 23 to be a separate component of member 19 which is coupled tocover 38 or for connecter 23 to be molded integrally with cover 38.Connector 40 includes a passageway formed at a right-angle. Thus, thepassageway in connector 40 has a vertical portion 25 that communicateswith port 52 and a horizontal portion 27 that communicates with verticalportion 25. Connector 40 connects with tube 41 to provide a horizontaltube attachment with respect to port 52. Cover 38 further includes abottom surface 56. Bottom surface 56 engages opposite surface 44 oflayer 36, as shown in FIG. 3.

As mentioned above, cover 38 is coupled to layer 36 and connecter 40 iscoupled to cover 38 to form member 19. Cover 38 and layer 36 cooperateto form distinct passageways 58 of member 19 defined by channels 48, 49of layer 36 and bottom surface 56 of cover 38. Passageways 58 are incommunication with central area 46 of layer 36 and central area 46 oflayer 36 is in communication with port 52 of cover 38 which is incommunication with the vacuum and/or irrigation sources 16, 18 viaconnecter 40 and tube 41. Therefore, passageways 58 are in communicationwith the vacuum and/or irrigation sources 16, 18.

Member 19 includes through holes 60 which extend from channels 48, 49through layer 36 to wound contacting surface 42, as shown in FIG. 3.Holes 60 are distinct and are provided to communicate with channels 48,49 of layer 36. Holes 60 therefore communicate with passageways 58 ofmember 19 and the vacuum and/or irrigation sources 16, 18 as well toallow the suction from the vacuum source 16 and/or the fluid from theirrigation source 18 to reach the wound surface 14 via the holes 60. Asshown in FIG. 3, holes 60 have a staggered arrangement. Illustratively,holes 46 are 0.020 inch (0.508 mm) in diameter and are spacedapproximately 0.500 (12.700 mm) apart along channels 48, 49 of layer 36.It is, however, within the scope of the disclosure to include holeshaving other suitable sized diameters and/or other suitable spacing thatallow for the removal of exudate without clogging.

Member 19 includes a smooth wound contacting surface 42, as shown inFIG. 3. Wound contacting surface 42 may also be textured or roughened.By providing member 19 with a textured or roughened surface, a space iscreated between surface 42 of layer 36 and wound surface 14. Throughholes 60 communicate with this space which permits vacuum source 16 toestablish a generally uniformly distributed vacuum or negative pressureto the wound surface 14 to draw blood from the body to the wound surface14 and to draw exudate from the wound 12 through holes 60, into channels48, 49 and passageways 58, and out port 52 of cover 38. It is within thescope of this disclosure to include other means for providing a spacebetween surface 42 and wound surface 14 such as providing ribs,protrusions, channels, spacers, etc.

As mentioned above, port 52 of cover 38 communicates with vacuum source16 and/or irrigation source 18 via connecter 40 and tube 41. As shown inFIG. 1, a switch valve 55 is provided which allows the caregiver toswitch between the use of the vacuum source 16 and the irrigation source18. It will be appreciated that a mechanism other than the switch valve55 maybe used selectively to couple the vacuum source 16 or theirrigation source 18 to the bandage. Simple tube clamps, for example,may be used selectively to open and close the tube set provided withbandage 11. When valve 55 is switched to operate the vacuum source 16,the vacuum suction draws exudate up through holes 60 and radiallyinwardly through passageways 58 toward port 52 and finally throughconnecter 40 and tube 41. Although illustrative bandage 11 includes onecentral port 52, it is within the scope of this disclosure to includemultiple ports. It is further within the scope of this disclosure toprovide an alternative member having multiple ports and multiplepassageway sets for use independent of each other.

As mentioned above, bandage 11 and kit 10 each further includes asealing layer or film 22 that is placed over cover 38 and around tube41, as shown in FIG. 1. Film 22 covers the entire wound 12 and extendsacross and attaches to the patient's healthy skin 62, also as shown inFIG. 1. Preferably, film 22 is an occlusive or semi-occlusive materialwhich allows moisture to permeate through. Because of thischaracteristic, the film 22 is referred to as Moisture VaporTransmission Rate film or MVTR film. As mentioned above, the productsTEGADERM® made by 3M Corporation and OPSITE FLEXGRID® made by Smith andNephew can be used for film 50, for example. The product OpSite™ is asemi-permeable film. Film 22 is approximately 0.003 inch (0.076 mm)thick. However, it is within the scope of this disclosure to include anyocclusive or semi-occlusive film 22 having another thickness. Film 22 isprovided to create a sealed environment below the film 22 and around thewound 12 in which a vacuum or negative pressure can be maintained asprovided by vacuum source 16. As shown in FIG. 9, film 22 includes anadhesive layer 23 and release liners 70 coupled to adhesive layer 23.Illustratively, layer 23 is an adhesive backed polyurethane film.Release liners 70 include a flap 71 to be grasped by the caregiver toremove each release liner 70 and progressively expose the adhesive belowfor attachment of adhesive layer 23 to the patient's healthy skin 62surrounding the wound 12.

Illustrative skin protectant 34 of kit 10 is CAVILON™ No-Sting Barrieravailable from 3M Corporation. Other manufactures includes BARD®Incontinence Protective Barrier Film by Bard Medical Division andNO-STING SKIN-PREP™ Protective Dressing by Smith & Nephew, for example.Skin protectant 34 is also referred to as skin barrier film. Skinprotectant 34 is typically applied as a liquid that is sprayed, swabbedor wiped on the patient's healthy skin 62 with an impregnated gauze. Theliquid is typically polymeric and is allowed to dry on the skin 62 toform a tin film that protects the healthy skin 62 from such things asurine and/or fecal incontinence, digestive juices, wound drainage,adhesives and friction, for example. Skin protectant 34 is also providedin kit 10 for the purpose of preventing the vacuum and irrigation tubing41 from creating a pressure sore on the patient's healthy skin 62. It iswithin the scope of this disclosure for kit 10 to include suitable skinprotectants other than those listed above.

Illustrative sterile cotton swabs or applicators 30 are provided on a6-inch (15.24 cm) wooden stick and are used for measuring the depth ofthe wound 12 for recordation in a patient's logbook, for example, tochart the progress of the healing of the wound 12. Although twoapplicators 30 are provided, only one applicator 30 is required formeasuring the depth of wound 12. An extra applicator is provided ifneeded by the caregiver. To measure the depth of wound 12, a caregiverinserts applicator 30 perpendicularly into wound 12 relative to thehealthy skin surrounding wound 12. Caregiver then either grasps the woodstick or shaft portion of the applicator 30 with his/her fingers orsimply marks the shaft with a pen or marker to indicate the depth of thewound 12. Using a ruler or other measuring device, the caregiver thenmeasures the distance on the applicator 30 between the cotton tip andtheir finger or mark to determine a numerical value for the depth ofwound 12 for recording in the patient's log book or records.

Illustrative wound tracing guide or wound measurement device 32, shownin FIGS. 1-3 is a transparent plastic film that is placed over the wound12. Device 32 includes a a first (e.g., top) sheet or portion 74, and asecond (e.g., bottom) sheet or portion 72 configured to be pulled fromfirst or top portion 74 (e.g., by way of a perforated line 76 separatingbottom portion 72 from top portion 74). Bottom portion 72 is transparentand includes a wound contacting surface 78 and an opposite surface 80which contacts top portion 74 when device 32 is folded along perforatedline 76, as shown in FIG. 6. Bottom portion 72 has a ruler 82 printed orotherwise provided thereon, as shown in FIG. 5. Illustrative ruler 82 isgraduated in centimeters for measurement of the length and/or width ofwound 12.

Top portion 74 of device 32 includes a drawing surface 84 and anopposite surface 86 for contact with opposite surface 80 of bottomportion 72 when device 32 is folded along the perforated line 76. Topportion 74 further includes an information recording area 88 for acaregiver to record such information as the patient's name oridentification number, the date, the location of the wound 12 on thepatient, the length and width of the wound 12, the depth of the wound 12including any amount of tunneling of the wound 12, and a measurement ofany undermining of the wound 12 which may be present. A grid 90 is alsoprinted or otherwise provided on top layer 74 of device 32. Grid 90,similar to ruler 82, is calibrated in centimeters.

In use, device 32 is placed on or over wound surface 14 of wound 12 whenthe vacuum bandage 11 is being changed by a caregiver. That is, device32 is place upon the wound surface 14 once sealing film 22, member 19,and gauze 20 (if used) have been removed from the wound 12 and beforeapplication of a new bandage 11 to wound 12. Device 32 is positioned sothat the wound contacting surface 78 of bottom layer 72 is above andgenerally adjacent wound surface 14 and the patient's healthy skin 62surrounding wound 12. Device 32 is next folded along perforated line 76to place opposite surface 86 of top layer 74 adjacent opposite surface80 of bottom layer 72. A caregiver then traces the shape of wound 12(i.e. the boundary between healthy skin and wound 12) onto grid 90 ofdrawing surface 84 of top layer 74, as shown for example in FIG. 7 bywound outline 92. Once the outline 92 of wound 12 has been traced,device 32 is torn (e.g., by pulling second or bottom portion 72 awayfrom first or top portion 74) along perforated line 76. Bottom portion72, which has been in contact with wound surface 14, is discarded. Toplayer 74 is maintained in the patient's log or records to record theprogress and healing of wound 12 for future reference. Thus, bottomlayer 72 prevents exudate, bacteria, etc. from wound 12 from contactingtop layer 74.

Kit 10 further includes an alternate means of measuring the size of thepatient's wound 12. As stated above, wound measurement device 32 isprovided to record the wound size for the patient's records. In analternate embodiment, member 19 includes a removable, peel-off plasticbacking (not shown). It is within the discretion of the caregiver to cutor trim member 19 to fit the size of the wound 12. Therefore, whenmember 19 is cut to fit the size of the wound 12, the backing is trimmedas well. This backing is then removed from the member 19 and filed withthe patient's records to record the size of the wound 12. It is withinthe scope of this disclosure for the backing to include an adhesive tostick to a sheet of paper within the patient's records, for example.

Kit 10 includes yet another means for recording the size of the wound12. For example, member 19 could be silk-screened with dimensionalmarkings. When member 19 is trimmed or cut to fit the wound 12 of thepatient, the remaining silk-screened marking on member 19 will indicatethe size of the wound 12 without the need for the caregiver to directlymeasure the size of the wound 12.

In order to accommodate different sized wounds 12, member 19 may betrimmed to fit a particular wound 12. Scissors 24 of kit 10 are used bya caregiver to trim member 19 to fit a particular wound 12. Anothermember, for example, shown in U.S. Patent Publication No. US2002/0082567 A1 and incorporated by reference herein, includes scalemarkings for indicating areas where a user may trim member 19 to fit aparticular wound 12. In one embodiment, the scale markings denotemeasurement sizes, for example, to permit a user to cut the member 19,using scissors 24, to fit a pre-measured wound 12. As mentioned above,the wound measurement device 32 is used to measure the size of the wound12.

Tape 28 of kit 10 is used at the discretion of the caregiver to helpseal film 22 to the patient's healthy skin 62 and/or to help secure tube41 in place to prevent tube 41 from becoming disengaged from bandage 11,for example. Illustratively, tape 28 is hypo-allergenic.

A patch sheet 94 of kit 10 is shown in FIGS. 7 and 8. Patch sheet 94 isan occlusive or semi-occlusive transparent film dressing, similar tosealing film 22, that is die-cut into strips 96 and patches 98, as shownin FIG. 7. These strips 96 and patches 98 are used by the caregiver torepair any unwanted leaks that may develop in film 22 during the courseof treatment.

Patch sheet 94 is made of the same material as sealing film 22 andincludes a first adhesive backed polyurethane layer 100 and a secondlayer 102 removably coupled to first layer 100. As shown in FIG. 7,first layer 100 is die-cut into patches 98 and strips 96 which arecoupled to second layer or release liner 102. Release liner 102 isremoved to expose an adhesive surface of layer 100. As shown in FIG. 9,patches 98 are circular and are shown in various sizes having ½ inch(12.7 mm), ¾ inch (19.05 mm), and 1 inch (2.54 cm) diameters, forexample. Further, strips 96 are shown in various sizes having ½ inch(12.7 mm), ¾ inch (19.05 mm), and 1 inch (2.54 cm) widths. The entireillustrative patch sheet 94 is 6 inches (15.24 cm) by 6 inches (15.24cm). It is within the scope of this disclosure, however, to includepatches and strips of any suitable size and shape for repairing unwantedleaks of the sealing film 22 which occur. It is further within the scopeof this disclosure for strips 96 and patches 98 to be dispensed on aroll.

In alternative embodiments, kit 10 further includes one or more of thefollowing: a sterile mask, a gown, or other infection control garments(not shown). The sterile mask, gown, and other garments are worn by thecaregiver to help maintain a clean environment and to prevent infectionof the wound 12. In another alternative embodiment, kit 10 includes awound cleanser (not shown) for cleaning wound 12 prior to prior todressing wound 12 with bandage 11. Current wound cleansers availableinclude Dermal Wound Cleanser by Smith & Nephew, CARRAKLENZ™ byCarrington Laboratories, Inc., and DermalHealth Wound Cleanser by DumexMedical. It is within the scope of this disclosure, however, to includea kit 10 having other suitable wound cleansers for cleansing anddisinfecting the wound surface 14.

A tube guide 110, shown in FIGS. 10-12, is also provided in illustratedkit 10. Tube guide 110 has an aperture 112 for receiving a portion ofvacuum/irrigation tube 41. As mentioned above, tube 41 is incommunication with port 52 of member 19 and with the vacuum and/orirrigation source 16, 18. Tube guide 110 aides in effectively sealingthe film 22 around tube 41 and to the patient's healthy skin 62 aroundwound 12 to create a sealed environment beneath film 22 and above woundsurface 14. Without the use of tube guide 110, film 22 is pinched aroundthe tube 41 by the caregiver to seal the film 22 against the patient'shealthy skin 62 surrounding wound 12. Tube guide 110 acts to prevent airleaks into the vacuum space created below film 22.

Guide 110 is manufactured from a low durometer or soft polymer such asPVC, for example. In one embodiment, guide 110 has a width 111 ofapproximately 1 inch (2.54 cm), a height 113 of approximately ⅜ inch(9.525 mm), and a depth 115 of approximately ⅜ inch (9.525 mm). As shownin FIGS. 10 and 11, aperture 112 of guide 110 has a diameter of ¼ inch(6.35 mm) and is therefore designed to accommodate a vacuum/irrigationtube having a ¼ inch (6.35 mm) outer diameter. It is within the scope ofthis disclosure, however, to include a guide 110 having any suitablewidth, height, and depth and including an aperture having any suitablediameter for receiving vacuum/irrigation tubes of various sizes.

Guide 110 includes a flat bottom surface 114 having a pre-appliedadhesive 116, as shown in FIG. 13. As shown in FIG. 14, bottom surface114 is adhered to the healthy skin 62 adjacent wound 12. Guide 110further includes a curved top surface 118. The bell-shaped contour oftop surface 118 allows the sealing film 22 to drape over tube guide 110and tube 41, rather than be pinched underneath tube 41. Therefore, guide110 allows a more effective seal to be created around tube 41. Thebell-shaped contour of top surface 118 includes a convex upper region117 that blends smoothly into curved lower regions 119 which terminateat thin end edges 121 adjacent the patient's skin 62.

Guide 110 has a slit or opening 120 between a first surface 122 and asecond surface 124 of guide 110. Opening 120 is in communication withaperture 112. As shown in FIGS. 12 and 13, surfaces 122 and 124 areparallel with respect to each other and are inclined with respect to thebottom surface 114. Opening 120 provides access to aperture 112. Tube 41is placed within aperture 112 by separating surfaces 122, 124 away fromeach other and sliding tube 41 through the enlarged opening 120 to bereceived within aperture 112. A diameter of aperture 112 isapproximately the same as an outer diameter of tube 41 to create agenerally air tight seal between tube guide 110 and tube 41 to preventoutside air from the atmosphere around bandage 11 from entering thespace above the wound 12 and possibly contaminating the wound surface14. Opening 120 causes guide 110 to be flexible such that surfaces 122,124 are movable relative to the bottom portion 114 and are urged to abuteach other when sealing film 22 is placed over guide 110.

Sealing film 22 is placed over the wound 12 and seals against the curvedtop surface 118 of guide 110 rather than sealing directly against tube41. As stated above, the contour of top surface 118 allows film 22 todrape over guide 110 to seal to top surface 118 of guide 110. Opening120 is therefore sealed by film 22. It is also within the scope of thisdisclosure to extrude a vacuum/irrigation tube having the profile of theguide 110, thus eliminating the need for guide 110.

The components of kit 10 may be used in the following order. Forexample, the gloves 26 and other infection control garments may be usedfirst. Next, the scissors 24 may be used to remove an old dressing, forexample. A caregiver may next use a wound cleanser included in kit 10 toclean wound 12 and one of the cotton-tipped applicators 30 to measurethe depth of the wound 12. Wound measurement device 32 may be used next,for example, to trace and record the perimeter of wound 12. Gauze 20 maynext be used by the caregiver to clean the wound surface 14 or absorbfluid collected at the wound surface 14, for example. Skin protectant 34may then be used to protect the patient's healthy skin 62 surroundingthe wound 12. Next, the caregiver may place the member 19 on top of thewound surface 14 and finally cover the member 19 and the wound 12 withsealing film 22. The tape and patch sheet 94 may be used to repair anyleaks which develop in the sealing film 22.

It is within the scope of this disclosure to package all components ofkit 10 in sterile conditions so that each component of kit 10 is sterileand ready for use. It is further within the scope of this disclosure topackage all components of kit 10 in such a manner that they aregenerally presented to the caregiver in the sequence that they arerequired during the dressing change of the wound 12, as described above.The packaging material of the kit 10 may be a thermo-formed, plastictray with a clear polyurethane lid, for example. The tray may be formedto include individually shaped cavities to form pouches for eachcomponent.

Kit 10 may also include one or more vents, venting lines, valves,stopcocks, and multi-lumen tubes or tube sets. Vents or venting linesmay be provided to circulate air through bandage 11, for example. Valvesor stopcocks may be provided to direct flow between vacuum source 16 andbandage 11 and between irrigation source 18 and bandage 11, such asswitch valve 55 diagrammatically illustrated in FIG. 1. Multi-lumentubes may connect member 19, or another such wound dressing member, withvents and/or stopcocks. Multi-lumen tubes may provide multiplepassageways for air, vacuum suction, and or irrigation fluids, forexample. Such vents, stopcocks and multi-lumen tubes are disclosed inPCT International Publication No. WO 03/057070; which was filedconcurrently herewith; which is titled VENTED VACUUM BANDAGE AND METHODwhich is hereby incorporated by reference herein.

Kit 10 may also include wound inserts or wound packing for use withtunneled and/or undermined wounds, for example. Such inserts areprovided to generally fill the open space created by various woundtunnels and/or undermined portions of wounds. Illustrative wound insertsare disclosed in PCT International Publication No. WO 2004/01820; whichwas filed concurrently herewith; which is title WOUND PACKING FORPREVENTING WOUND CLOSURE which is hereby incorporated by referenceherein.

Kit 10 may also include collars to provide external catheter access (fortube 41, for example) to vacuum bandage 11, and bandage packing to beplaced between member 19 and sealing film 22. Illustrative collars andbandage packing can be found in PCT International Publication No. WO03/073970; which was filed concurrently herewith; which is titledEXTERNAL CATHETER ACCESS TO VACUUM BANDAGE which is hereby incorporatedby reference herein; and in PCT International Publication NO. WO03/057071; which was filed concurrently herewith; which is titled VACUUMBANDAGE PACKING which is hereby incorporated by reference herein.

Although this invention has been described in detail with reference tocertain embodiments, variations and modifications exist within the scopeand spirit of the invention as described and defined in the followingclaims.

1. A wound vacuum therapy dressing kit for use with a wound drainagesystem having a vacuum source, the kit comprising: a wound dressingmember having a wound contacting surface configured to be in contactwith and generally conform to a wound surface of a patient, the memberbeing adapted to be coupled to the vacuum source for communicatingsuction from the vacuum source to the wound surface, a sealing film forplacement over the member and configured to adhere to a patient'shealthy skin surrounding the wound, and a wound measurement devicecomprising a perforated transparent film without adhesive including afirst portion and a second portion removably coupled to the firstportion and configured to be pulled from the first portion, the filmconfigured to be folded such that (i) substantially all of a firstsurface of the first portion contacts a first surface of the secondportion and (ii) the second surface of the second portion is configuredfor placement adjacent the wound surface, a second surface of the firstportion including an exposed drawing surface and a grid that overliesthe second portion when the first portion is folded relative to thesecond portion.
 2. The kit of claim 1, further including a tube guideconfigured to be coupled to the healthy skin adjacent the wound andhaving an aperture configured to receive a portion of a vacuum tube ofthe wound vacuum drainage system that extends between the member and thevacuum source.
 3. The kit of claim 2, wherein the tube guide includes acurved upper surface and the sealing film is configured to drape overand seal to the curved upper surface.
 4. The kit of claim 3, wherein thetube guide includes a generally flat bottom surface and an adhesivelayer coupled to the bottom surface.
 5. The kit of claim 2, wherein thetube guide further includes a first end and a second end spaced apartfrom the first end to define an opening in communication with theaperture and configured to pass the vacuum tube therethrough forplacement of the vacuum tube within the aperture.
 6. The kit of claim 1,further including a patch sheet having a first adhesive layer and asecond layer removably coupled to the first layer.
 7. The kit of claim6, wherein the first layer of the patch sheet includes patches andstrips configured to be removed from the second layer of the patch sheetand placed over unwanted leaks in the film for use with the sealing filmto seal about the member and create a vacuum space above the wound. 8.The kit of claim 7, wherein each of the patches has a diameter of ½ inch(12.7 mm), ¾ inch (19.05 mm), or 1 inch (2.54 cm).
 9. The kit of claim7, wherein each of the strips is 6 inches (15.24 cm) in length and has awidth of ½ inch (12.7 mm), ¾ inch (19.05 mm), or 1 inch (2.54 cm). 10.The kit of claim 1, wherein the sealing film includes multiple releaseliners removably coupled to an adhesive back polyurethane layer.
 11. Thekit of claim 1, wherein the second portion of the wound measurementdevice includes a ruler.
 12. The kit of claim 11, wherein the firstportion of the wound measurement device further includes an informationrecording area for recording a patient's data information.
 13. A woundvacuum therapy dressing kit for use with a wound drainage system havinga vacuum source, the kit comprising: a generally non-compressible wounddressing member having a wound contacting surface configured to be incontact with and generally conform to a wound surface of a wound, asealing film for placement over the member and configured to adhere to apatient's healthy skin surrounding the wound, a patch sheet having afirst adhesive layer and a second layer removably coupled to the firstlayer, the first layer having a patches and strips configured to beremoved from the second layer and placed over unwanted leaks in thefilm, infection control garments, applicators configured to measure adepth of the wound, and scissors configured to trim the member to fitthe wound, wherein the kit further comprises a wound measurement devicecomprising a transparent film including a first portion and a secondportion removably coupled to the first portion, the film configured tobe folded such that (i) substantially all of a first surface of thefirst portion contacts a first surface of the second portion and (ii)the second surface of the second portion is configured for placementadjacent the wound surface, a second surface of the first portionincluding an exposed drawing surface and a grid that overlies the secondportion when the first portion is folded relative to the second portion,and wherein the film is perforated.
 14. A wound vacuum therapy dressingkit for use with a wound drainage system having a vacuum source, the kitcomprising: a wound dressing member having a wound contacting surfaceconfigured to be in contact with and generally conform to a woundsurface of a patient, the member being adapted to be coupled to thevacuum source for communicating suction from the vacuum source to thewound surface, and a wound measurement device comprising a transparentfilm including a first portion and a second portion removably coupled tothe first portion, the film configured to be folded such that (i)substantially all of a first surface of the first portion contacts afirst surface of the second portion and (ii) the second surface of thesecond portion is configured for placement adjacent the wound surface, asecond surface of the first portion including an exposed drawing surfaceand a grid that overlies the second portion when the first portion isfolded relative to the second portion, wherein the film is perforatedand wherein the film is configured to allow the second portion to bepulled from the first portion.
 15. A wound vacuum therapy dressing kitfor use with a wound drainage system having a vacuum source, the kitcomprising: a wound dressing member having a wound contacting surfaceconfigured to be in contact with and generally conform to a woundsurface of a patient, the member being adapted to be coupled to thevacuum source for communicating suction from the vacuum source to thewound surface, and a wound measurement device comprising a transparentfilm including a first portion and a second portion removably coupled tothe first portion, the film configured to be folded such that (i)substantially all of a first surface of the first portion contacts afirst surface of the second portion and (ii) the second surface of thesecond portion is configured for placement adjacent the wound surface, asecond surface of the first portion including an exposed drawing surfaceand a grid that overlies the second portion when the first portion isfolded relative to the second portion, wherein the second portion of thewound measurement device includes a ruler.
 16. The kit of claim 14,wherein the kit further comprises a tube guide configured to be coupledto healthy skin adjacent the wound and having an aperture configured toreceive a portion of a vacuum tube of the wound drainage system thatextends between the member and the vacuum source.
 17. The kit of claim16, wherein the tube guide includes a generally flat bottom surface andan adhesive layer coupled to the bottom surface.
 18. The kit of claim16, wherein the tube guide includes a generally convex top surface. 19.The kit of claim 14, wherein the member comprises a generally non-porousand generally non-compressible material.
 20. The kit of claim 19,wherein the member is made of a medical grade silicone.
 21. The kit ofclaim 19, wherein the wound contacting surface of the member includesholes in communication with the wound surface and the member furtherincludes a port and a passageway between the port and each hole.
 22. Thekit of claim 13, wherein the second portion of the wound measurementdevice includes a ruler.